- For the three months ended September 30, 2016, total prescriptions filled for Adzenys XR-ODT, as reported by IMS, were 8,959. For the four-week period ending October 28, 2016, IMS reported an additional 5,177 prescriptions filled for Adzenys XR-ODT.
- Since the launch in May 2016 through October 28, 2016, the cumulative total number of prescriptions filled, as reported by IMS, were 15,186.
- Weekly prescriptions increased approximately 13% per week during the three months ended September 30, 2016.
- Patients switching from another ADHD medication accounted for approximately 75% of all new Adzenys XR-ODT prescriptions, as reported by IMS.
- As of the week ended October 21, 2016, as reported by IMS, 62% of all new Adzenys XR-ODT prescriptions were for pediatric patients and 38% were for adult patients, indicating a broad appeal of Adzenys XR-ODT in all patient types.
- The number of new prescribers has continued to grow since launch. The cumulative total number of prescribers of Adzenys XR-ODT, as reported by IMS through the week ended October 21, 2016, was 2,887.
- Managed care coverage for Adzenys XR-ODT has increased to 83% of lives covered by commercial payers compared to 70% covered lives in the last quarter.
- Resubmit the New Drug Application (NDA) for Cotempla XR-ODT, the Company's methylphenidate extended-release ODT product, in the fourth quarter of 2016.
- Submit the NDA for NT-0201, the Company's amphetamine XR liquid suspension, in the fourth quarter of 2016.
- Total product revenues were $1.6 million for the three months ended September 30, 2016, compared to $0.2 million for the same period in 2015. Adzenys XR-ODT revenues were approximately $0.7 million, and the remainder of the increase is attributed to an increase in sales of the Company's generic Tussionex.
- Gross loss for the three months ended September 30, 2016 was $0.7 million, compared to $1.0 million for the same period of 2015. This improvement was due to increased revenue offset by the cost of goods for the increased volume of product sales.
- Research and development expenses for the three months ended September 30, 2016 were $2.9 million, compared to $2.7 million for the same period in 2015. This increase was primarily due to completion of the bioequivalence studies for Cotempla XR-ODT and NT-0201.
- Selling and marketing expenses were $17.0 million for the three months ended September 30, 2016, compared to $1.4 million for the same period in 2015. The increase is primarily directly attributable to the commercialization of Adzenys XR-ODT, which launched in May 2016.
- General and administrative expenses for the three months ended September 30, 2016 were $3.1 million, compared to $2.0 million for the same period in 2015. This increase was a result of higher professional fees and salary and compensation expenses associated with becoming a public reporting and commercial company.
- The Company reported a net loss of $25.8 million in the three months ended September 30, 2016, compared to $9.4 million for the same period in 2015.
- At September 30, 2016, the Company's cash, cash equivalents and short-term investments amounted to $60.0 million.
- Global Mizuho Investor Conference, New York City, November 14 th
- Stifel 2016 Healthcare Conference, New York City, November 15 th
- BMO Capital Markets Prescriptions for Success Healthcare Conference, New York City, December 14 th
|Neos Therapeutics, Inc. and SubsidiariesCONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)|
|In thousands, except share and per share data||September 30, 2016||December 31, 2015|
|Cash and cash equivalents||$||43,489||$||90,763|
|Accounts receivable, net of allowances of $1,193 and $1,039, respectively||4,263||3,903|
|Other current assets||1,980||1,058|
|Total current assets||71,962||98,244|
|Property and equipment, net||6,952||5,124|
|Intangible assets, net||15,969||16,672|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Current portion of long-term debt||3,188||7,973|
|Total current liabilities||21,414||15,938|
|Long-term debt, net of current portion||58,524||26,271|
|Deferred gain on leaseback||60||547|
|Total long-term liabilities||60,123||28,198|
|Preferred stock, $0.001 par value, 5,000,000 shares authorized, no shares issued or outstanding at September 30, 2016 and December 31, 2015||-||-|
|Common stock, $0.001 par value, 100,000,000 authorized at September 30, 2016 and December 31, 2015; 16,079,902 and 16,070,705 issued and outstanding at September 30, 2016 respectively; 16,025,155 and 16,015,958 issued and outstanding at December 31, 2015, respectively||16||16|
|Treasury stock, at cost, 9,197 shares at September 30, 2016 and December 31, 2015||(171||)||(171||)|
|Additional paid-in capital||197,789||195,314|
|Accumulated other comprehensive income||9||-|
|Total stockholders' equity||15,898||78,374|
|Total liabilities and stockholders' equity||$||97,435||$||122,510|
|Neos Therapeutics, Inc. and Subsidiaries CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)|
|For the Three Months Ended September 30,||Nine Months Ended September 30,|
|In thousands, except share and per share amounts||2016||2015||2016||2015|
|Net product sales||$||1583||$||221||$||5,651||$||2,133|
|Cost of goods sold||2,289||1,172||7,301||4,070|
|Research and development||2,910||2,658||8,722||8,965|
|Selling and marketing expenses||16,977||1,399||39,630||2,370|
|General and administrative expenses||3,140||1,967||9,600||4,891|
|Loss from operations||(23,733||)||(6,975||)||(59,602||)||(18,163||)|
|Loss on debt extinguishment||-||-||(1,187||)||-|
|Other income, net||155||518||716||623|
|Change in fair value of earnout and warrant liabilities||(98||)||(1,867||)||(141||)||(1,452||)|
|Preferred stock accretion to redemption value||-||(99||)||-||(1,169||)|
|Preferred Stock Dividends||-||(138||)||-||(1,221||)|
|Net loss attributable to common stock||$||(25,806||)||$||(9,605||)||$||(64,960||)||$||(24,067||)|
|Weighted average common shares outstanding used to compute net loss per share, basic and diluted||16,070,705||12,403,182||16,048,801||4,767,479|
|Net loss per share of common stock, basic and diluted||$||(1.61||)||$||(0.77||)||$||(4.05||)||$||(5.05||)|
Contacts: Richard EisenstadtChief Financial OfficerNeos Therapeutics(972) email@example.comSarah McCabeStern Investor Relations, Inc.(212) firstname.lastname@example.org